GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

Inclusion Criteria

• Patients must have a history of histologic or cytologic diagnosis of primary ovarian, primary peritoneal or tubal carcinoma.
• Patients must be asymptomatic from their cancer.
• Patients must have evidence of recurrent carcinoma, as determined by:
• A rising cancer antigen 125 (CA-125) serum level greater than 35 U/mL or two successive rising values with the most recent value at least 3 times the nadir value.
• Or evidence of evaluable or measurable disease by x-ray or computed tomography (CT) scan.
• Patients may not receive concurrent antineoplastic therapy. All hormonal therapy used as a treatment modality (i.e. tamoxifen, arimidex, etc) must be stopped prior to treatment on protocol.
• Age > 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status < 2.

Exclusion Criteria

• Known severe hypersensitivity to GM-CSF.
• Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or concurrent superficial or stage IB endometrial carcinoma.
• Concomitant use of anti-neoplastic therapy.
• Treatment with a non-FDA approved or investigational drug within 30 days before Day 1 of trial treatment.
• Any unresolved chronic toxicity greater then Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy (except alopecia).
• Serum creatinine level greater than CTC grade 2 [1.5 x upper limit normal (ULN)].
• Pregnancy or breast feeding (women of childbearing potential).
• Severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as judged by the investigator.
• Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate in the trial as judged by the investigator.
• Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment.
• Patients with clinical and/or radiographic evidence of current or impending bowel obstruction.
• Performance status < 1.
• Ability to understand and the willingness to sign a written informed consent document.